Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02298088
Other study ID # TREAT01
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date August 2015
Est. completion date January 2019

Study information

Verified date February 2019
Source Hospital do Coracao
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Administration of Ticagrelor in patients with ST elevation myocardial infarction treated with pharmacological thrombolysis


Description:

Phase III, Randomized, International, Multicenter, Open label, with Blinded Adjudication of Outcomes, Non-Inferiority Clinical Trial to Explore the Safety and Efficacy of Ticagrelor Compared with Clopidogrel in Patients with Acute Coronary Syndrome with ST Elevation Treated with Pharmacological Thrombolysis.


Recruitment information / eligibility

Status Completed
Enrollment 3799
Est. completion date January 2019
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Patients of both sexes aged = 18 years and < 75 years with ACS with ST segment elevation with onset during the previous 24 hours, documented by cardiac ischemic symptoms due to atherosclerosis of > 10 minutes duration at rest, treated with pharmacological thrombolysis

- Fibrinolytic therapy should be given to patients with STEMI and onset of ischemic symptoms within the previous 12 hours

Patients with acute coronary syndrome with ST segment elevation will be included provided they present ST segment elevation at the J point in two contiguous leads in electrocardiogram with cut-points: > 0.1mV in all leads other than leads V2-V3, where the following cut points apply: > 0.2 mV in men > 40 years; > 0.25 mV in men < 40 years, or >0.15 mV in women and at least 1 of the following criteria:

- Angina-like chest pain or ischemic equivalent chest pain;

- Abnormalities above the reference value for markers of myocardial necrosis (troponin and CK-MB).

The patient must be able to give informed consent in accordance with ICH GCP guidelines and local legislation and/or regulations.

Exclusion Criteria:

- Any contraindication against the use of clopidogrel (eg, hypersensitivity, moderate or severe liver disease, active bleeding or bleeding history, history of intracranial hemorrhage)

- Need for oral anticoagulation therapy,

- Concomitant oral or IV therapy with strong CYP3A inhibitors (ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, grapefruit juice N1 L/d), CYP3A substrates with narrow therapeutic indices (cyclosporine, quinidine), or strong CYP3Ainducers (rifampin/rifampicin, phenytoin, carbamazepine)

- Increased risk of bradycardia events

- Dialysis required

- Known clinically important thrombocytopenia

- Known clinically important anemia

- Any other condition that may put the patient at risk or influence study results in the investigators' opinion (eg, cardiogenic shock, severe hemodynamic instability, active cancer)

- Participant in another investigational drug or device study within 30 d

- Pregnancy or lactation

- Any condition that increases the risk for noncompliance or being lost to follow-up

- Involvement in the planning or conduct of the study

- Previous enrollment or randomization in this study

- Contraindications to fibrinolytic therapy including: 15

- Any prior intracranial hemorrhage

- Known structural cerebral vascular lesion (eg, Arterial Venous Malformation - AVM)

- Known malignant intracranial neoplasm (primary or metastatic)

- Ischemic stroke within 3 months

- Suspected aortic dissection

- Active bleeding or bleeding diathesis (excluding menses)

- Significant closed head trauma or facial trauma within 3 months

Study Design


Related Conditions & MeSH terms

  • Acute ST Segment Elevation Myocardial Infarction
  • Infarction
  • Myocardial Infarction
  • ST Elevation Myocardial Infarction
  • Thrombolysis in Myocardial Infarction Flow

Intervention

Drug:
Ticagrelor 180 mg
Ticagrelor, 180 mg as early as possible after the index event and not >24 h post event followed by 90 mg twice daily for 12 months.
Clopidogrel
300 mg clopidogrel as early as possible after the index event and not > 24h post event, followed by 75mg/day for 12 months. For patients with > 75 years the recommended load dose is 75 mg instead 300 mg.

Locations

Country Name City State
Argentina Hospital Interzonal General de Agudos Dr, José Penna Bahia Blanca
Argentina Hospital Alvarez Ciudad Autonoma de Buenos Aires
Argentina Hospital Del Cruce Nestor Kishner Florencio Varela
Argentina Hospital Español de La Plata La Plata
Argentina Sanatorio Modelo de Quilmes Quilmes
Argentina Hospital Zenón Santillan San Miguel de Tucuman
Australia Flinders Medical Centre Adelaide
Australia Royal Adelaide Hospital Adelaide
Australia Cairns Hospital Cairns
Australia The Alfred Hospital Melbourne
Australia Mildura Hospital Mildura
Australia John Hunter Hospital Newcastle
Australia Fiona Stanley Hospital Perth
Australia Liverpool Hospital Sydney
Australia Townsville Hospital Townsville
Australia Wollongong Hospital Wollongong
Brazil Hospital das Clínicas - UFMG Belo Horizonte
Brazil Hospital Lifecenter Belo Horizonte
Brazil Hospital Universitario Sao Jose Belo Horizonte
Brazil Santa Case de Belo Horizonte Belo Horizonte
Brazil Hospital de Base do Distrito Federal Brasília
Brazil Instituto de Cardiologia do Distrito Federal Brasília
Brazil Hospital de Clinicas da Universidade Estadual de Campinas - UNICAMP Campinas
Brazil Hospital e Maternidade Celso Pierro Campinas
Brazil Hospital e Clinica Sao Roque Ipiau
Brazil Hospital e Pronto Socorro 28 de Agosto Manaus
Brazil Hospital de Messejana Messejana
Brazil Santa Casa de Montes Claros Montes Claros
Brazil Hospital Sao Vicente de Paulo Passo Fundo
Brazil Hospital Pronto Socorro e Maternidade Santa Lucia Pocos de Caldas
Brazil Instituto de Cardiologia - Fundação de Cardiologia (ICFUC) Porto Alegre
Brazil Hospital Agamenon Magalhaes Recife
Brazil Hospital Municipal de Emergencia Albert Sabin Sao Caetano do Sul
Brazil Santa Casa de Sao Jose do Rio Preto Sao Jose do Rio Preto
Brazil Hospital do Coracao Sao Paulo
Brazil Hospital do Mandaqui Sao Paulo
Brazil Hospital Geral do Grajau / UNISA Sao Paulo
Brazil Hospital Municipal do Campo Limpo Sao Paulo
Brazil Hospital TotalCor Sao Paulo
Brazil PreventSenior Sao Paulo
Brazil Universidade Federal de Sao Paulo Sao Paulo
Brazil Cardiolima Teresina
Canada Royal Alexandra Hospital Edmonton
Canada University of Alberta Hospital Edmonton
Canada Queen Elizabeth II Health Sciences Centre Halifax
Canada University Hospital / London Health Sciences Centre - Interventional Cardiology London
Canada Southlake Regional Health Centre - Interventional Cardiology Newmarket
Canada University of Ottawa Heart Institute Ottawa
Canada Peterborough Regional Health Centre Peterborough
Canada Inst Uni de Cardiologie et Pneumologie de Quebec Quebec
Canada Regina General Hospital - Prairie Vascular Research Network (PVRN) - SETFAST Coordinating Centre (SCC) Regina
Canada New Brunswick Heart Centre Research Initiative Saint John
Canada Centre Hospitalier Universitaire de Sherbrooke Sherbrooke
Canada Thunder Bay Regional Health Sciences Centre - Cardiac Cath Lab Thunder Bay
Canada Centre Intégré Universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec Trois-Rivieres
Canada Victoria Heart Institute Foundation Victoria,
Canada St. Mary's General Hospital Waterloo
Canada Windsor Regional Hospital Windsor
Canada St. Boniface General Hospital Winnipeg
China Alxa League Central Hospital Alashan
China Anshan Changda Hospital Anshan
China Third affiliated hospital of Inner Mongolia medical university Baotou
China Urad Front Banner People's Hospital Bayan Nur
China The First Hospital of Fangshan District, Beijing Beijing
China Benxi Jinshan Hospital Benxi
China Binzhou City Center Hospital Binzhou
China Changyuan County People's Hospital Changyuan
China Chaoyang Second People's Hospital Chaoyang
China Dengfeng People's Hospital Dengfeng
China Dunhua Hospital Dunhua
China Fushun Mining Bureau General Hospital Fushun
China Gongyi People's Hospital Gongyi
China Hulunbuir People's Hospital Harbin
China Qi County People's Hospital Hebi
China Heze Municipal Hospital Heze
China Hunchun People's Hospital Hunchun
China Wen Country People´s Hospital Jiaozuo
China Laixi People's Hospital Laixi
China The Second Hospital of Liaocheng Liaocheng
China The Third People's Hospital of LiaoYang Liaoyang
China Dongfeng County Hospital Liaoyuan
China Houma People's Hospital Linfen
China Lingbao First People's Hospital Lingbao
China Ruyang People's Hospital Luoyang
China Anhui Province Mengcheng County, People's Hospital Mengcheng
China Puyang Zhongyuan Oil field General Hospital Puyang
China Qinyang People's Hospital Qinyang
China Sanmenxia Central Hospital Sanmenxia
China Shangqiu Changzheng People's Hospital Shangqiu
China Shenyang Sujiatun District Central Hospital Shenyang
China Shenyang the Fourth Hospital of People Shenyang
China Xinmin People's Hospital Shenyang
China Jingxing County Hospital Shijiazhuang
China Laoting Hospital Tangshan
China Wuchuan People's Hospital Wuchuan
China Wuhai People's Hospital Wuhai
China Affiliated PuAi Hospital of Tongji Medical College Wuhan
China Wuyishan Municipal Hospital Wuyishan
China Qinghai Cardiovascular Hospital Xining
China Feng County People's Hospita Xuzhou
China Yongcheng People's Hospital Yongcheng
China Jiang Hua Yao Autonomous County People's Hospital Yongzhou
China The First People's Hospital of YueYang Yueyang
China Zhangye People's Hospital Zhangye
China Dancheng County People's Hospital Zhoukou
China Huaiyang County People's Hospital Zhoukou
Colombia Foundation Cardiomet Cequin Armenia
Colombia Centro de Diagnostico Cardiologico Ltda Cartagena
New Zealand Hawkes Bay Hospital Hastings
New Zealand Nelson Hospital Nelson
New Zealand Taranaki Hospital New Plymouth
New Zealand Rotorua Hospital Rotorua
New Zealand Tauranga Hospital Tauranga
New Zealand Thames Hospital Thames
New Zealand Whangarei Base Hopsital Whangarei
Peru Hospital Regional Lamabayeque Chiclayo
Peru Clínica Internacional Lima
Peru Clínica San Pablo Lima
Peru Hospital Cayetano Heredia Lima
Peru Hospital Hipólito Unanue Lima
Russian Federation Regional State Budget Healthcare Institution Altai Regional Cardiology Dispensary Barnaul
Russian Federation State Healthcare Institution "Belgorod regional clinical hospital named after Prelate Ioasaf Belgorod
Russian Federation State Budget Healthcare Institution "Chelyabinsk regional clinical hospital #3" Chelyabinsk
Russian Federation State Budget Healthcare Institution Leningrad region Gatchina Clinical Inter-district Hospital Gatchina
Russian Federation State Healthcare Institution Irkutsk regional clinical hospital Irkutsk
Russian Federation Kirov Regional State Budget Healthcare Institution Kirov City clinical hospital #1 Kirov
Russian Federation Regional State Budget Healthcare Institution Krasnoyarsk Regional Clinical Hospital Krasnoyarsk
Russian Federation Municipal Healthcare Institution Lyubertsy regional Hospital #2 Lyubertsy
Russian Federation State Regional Budget Healthcare Institution Murmansk region Clinical Hospital named after P.A. Bayandin Murmansk
Russian Federation State Budget Healthcare Institution Novosibirsk region City Clinical Hospital #34 Novosibirsk
Russian Federation Institution of the Russian academy of sciences Hospital of Pushchino Research Center of RAS Pushchino
Russian Federation Municipal Budget Healthcare Institution Rostov-on-Don City Emergency Care Hospital Rostov-on-Don
Russian Federation State Budget Healthcare Institution Ryazan region Regional Clinical Hospital Ryazan
Russian Federation State Budget Educational Institution of Higher Professional Education "Smolensk State Medical University" Ministry of Healthcare of Russian Federation, clinical facility is State Budget Healthcare Institution "Smolensk regional clinical hospital" Smolensk
Russian Federation Federal State Budget Science Institution "Science and Research Institute of Cardiology" Tomsk
Russian Federation State Healthcare Institution of Tula Region "Tula regional clinical hospital Tula
Russian Federation Tver Regional Clinical Hospital Tver
Russian Federation State Budget Healthcare Institution Vladimir region City Hospital #4 Vladimir
Russian Federation Budget Healthcare Institution Voronezh region City Clinical Emergency Care Hospital #1 Voronezh
Russian Federation State Budget Healthcare Institution of Yaroslavl region "Regional clinical hospital" Yaroslavl
Ukraine Cherkasy Regional Cardiology Center, Department of Acute Heart Failure and Arrythmia Cherkasy
Ukraine Ivano-Frankivsk Regional Clinical Cardiological Dispensary, Department of Anestesiology and Intensive Care, SI"Ivano-Frankivsk National Medical University", Chair of Internal Medicine ?2 and nurcering Ivano-Frankivsk
Ukraine Municipal Healthcare Institution "Kharkiv City Clinical Hospital #8", Cardiology Department for MI patients N1, Kharkiv Medical Academy of Postgraduate Education Kharkiv
Ukraine SI "National Institut of Therapy named after L.T. Malaya NAMS of Ukraine", Department of Acute Myocardial Infarction Kharkiv
Ukraine Kiev Oleksandrivsk Clinical Hospital, department of Cardiology Reanimation, National Medical University named after O.O. Bogomolets, Chair of Internal Medicine ?2 Kyiv
Ukraine Kyiv City Clinical Hospital #1, Department of Emergency Cardiology Kyiv
Ukraine Kyiv Emergency Care Hospital, Infarction Department Kyiv
Ukraine City Clinical Hospital # 1 Mykolaiv
Ukraine MI "City Clinical Hospital N3 named after prof. K.J. Alejnikovoi", department of intensice cardiology care unit Odesa
Ukraine MI "Rivne Regional Clinical Hospital" Rivne
Ukraine Sumy regional Cardiology Dispensary Sumy
Ukraine MI "Regional Medical Center of Cardiovascular Diseases" of Zaporizhzhia Regional Council, Intensive Care Unit Zaporizhzhya
Ukraine Municipal Institution " Central city clinical hospital N1", cardiology department for MI patients Zhytomyr

Sponsors (1)

Lead Sponsor Collaborator
Hospital do Coracao

Countries where clinical trial is conducted

Argentina,  Australia,  Brazil,  Canada,  China,  Colombia,  New Zealand,  Peru,  Russian Federation,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety Outcome as a measure of Time to TIMI-defined first major bleeding The primary safety endpoint is time to TIMI-defined and adjudicated first major bleeding event (including major life-threatening bleeding and other major bleeding).
Bleeding TIMI Definition
Major:
Any intracranial hemorrhage (ICH)*, OR Clinically significant overt signs of hemorrhage associated with a drop in hemoglobin (Hgb) of = 5 g/dL (or, when Hgb is not available, an absolute drop in hematocrit (Hct) of = 15%).
An independent blinded central adjudication committee will adjudicate all suspected primary end points.
30 days
Secondary Efficacy Outcome as a measure of major cardiovascular events Secondary efficacy combined endpoint: death from vascular causes, myocardial infarction, stroke, severe recurrent ischemia, recurrent ischemia, TIA, or other arterial thrombotic event.
We will also measure the individual outcomes all-cause mortality and need for rescue PCI, as well as individual components of the combined efficacy endpoint.
12 months
Secondary Safety Outcome as a measure of bleeding event Secondary safety endpoints: Total bleeding (major and minor) according to PLATO, TIMI and BARC definitions, minor bleeding according to the TIMI definition and major bleeding as individual endpoint according to the PLATO definition. Others safety variables will include: dyspnea, arrhythmia, bradycardia and laboratory safety tests 12 months
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06435728 - Predictive Value of Combining AccuIMR and AccuFFR in Patients With STEMI
Completed NCT02914795 - Platelet Function in Resuscitated Patients
Recruiting NCT00697021 - Thromboelastography As An Assessment Tool for Possible Clopidogrel and Aspirin Resistance Phase 3
Completed NCT05949515 - Retrospective Evaluation of SuperSaturated Oxygen (SSO2) Therapy Clinical Utility
Completed NCT02828683 - Safety and Efficacy of TCD-10023 (Ultimaster) Drug-eluting Stent in STEMI Patients - MASTER Study N/A
Completed NCT01986803 - ABSORB STEMI: the TROFI II Study N/A
Active, not recruiting NCT01878344 - Effects of N-acetyl Cysteine During Primary Percutaneous Coronary Intervention Phase 3
Withdrawn NCT02048085 - Comparing Ticagrelor and Clopidogrel Pharmacodynamics After Thrombolysis Phase 4
Completed NCT04463251 - Study to Evaluate the Effect on Parameters of Systemic Inflammation and Disease Outcomes and Safety of RPH-104 in Subjects With Acute ST-elevation Myocardial Infarction Phase 2
Active, not recruiting NCT02943954 - FLOW Evaluation to Guide Revascularization in Multi-vessel ST-elevation Myocardial Infarction N/A
Active, not recruiting NCT02067091 - Performance of Bioresorbable Scaffold in Primary Percutaneous Intervention of ST Elevation Myocardial Infarct Phase 3
Completed NCT01787110 - An Efficacy and Outcome Study of Supplemental Oxygen Treatment in Patients With Suspected Myocardial Infarction Phase 3
Recruiting NCT03137212 - Safety and Efficacy of Percutaneous Coronary Intervention Combined With Thrombolysis at Different Time N/A
Not yet recruiting NCT05802667 - A Cohort Study of Correlation Between Mast Cells and Prognosis in Patients With Acute Myocardial Infarction
Completed NCT04730778 - Predictive Value of CHA2DS2VASC Score for Contrast-induced Nephropathy After Primary Percutaneous Coronary Intervention in ST-segment Elevation Myocardial Infarction Patients